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US Food and Drug Administration (FDA) - Orthopedic Devices Registration
FDA Registered Orthopedic Devices - Updated May 2006

What Is Medical Device Listing?

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing. 		FDA Devices
FDA Devices
FDA Devices
FDA Devices


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Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   SAME
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  A. HENNISS.
Classification:   CALIPER
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  OLREN INSTRUMENTE.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF BONE RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  NEUFELD N.R..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGUERS & MORSELIZERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MTI MEDIZIN-TECHNISCHE INSTRUMENTE GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (VARIOUS TYPES)
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (MULTIPLE BRANDS)
Registered Establishment Name:  MTI MEDIZIN-TECHNISCHE INSTRUMENTE GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS TYPES OF HAND DRILLS
Proprietary Device Name:   BRACE, DRILL (MULTIPLE BRANDS)
Registered Establishment Name:  MTI MEDIZIN-TECHNISCHE INSTRUMENTE GMBH.
Classification:   BIT, DRILL
Generic Device Name:   BIT, DRILL (VARIOUS TYPES)
Proprietary Device Name:   BIT, DRILL (MULTIPLE BRANDS)
Registered Establishment Name:  MTI MEDIZIN-TECHNISCHE INSTRUMENTE GMBH.
Classification:   SKID, BONE
Generic Device Name:   BONE, SKID, VARIOUS TYPES
Proprietary Device Name:   BONE, SKID, VARIOUS TYPES
Registered Establishment Name:  SCHAD MEDICAL INSTRUMENTS GMBH.
Classification:   AWL
Generic Device Name:   AWL, VARIOUS TYPES
Proprietary Device Name:   AWL, VARIOUS TYPES
Registered Establishment Name:  SCHAD MEDICAL INSTRUMENTS GMBH.
Classification:   BIT, DRILL
Generic Device Name:   DRILL BITS, VARIOUS TYPES
Proprietary Device Name:   DRILL BITS, VARIOUS TYPES
Registered Establishment Name:  SCHAD MEDICAL INSTRUMENTS GMBH.
Classification:   GAUGE, DEPTH
Generic Device Name:   GAUGE, VARIOUS TYPES
Proprietary Device Name:   GAUGE, VARIOUS TYPES
Registered Establishment Name:  SCHAD MEDICAL INSTRUMENTS GMBH.
Classification:   RONGEUR
Generic Device Name:   RONGEUR, VARIOUS TYPES
Proprietary Device Name:   RONGEUR, VARIOUS TYPES
Registered Establishment Name:  SCHAD MEDICAL INSTRUMENTS GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVERS, VARIOUS TYPES
Proprietary Device Name:   SCREWDRIVERS, VARIOUS TYPES
Registered Establishment Name:  SCHAD MEDICAL INSTRUMENTS GMBH.
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS TYPES OF ARTHROSCOPIC ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KOSCHER & WURTZ GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  KOSCHER & WURTZ GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KOSCHER & WURTZ GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WIRE CUTTERS
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  NORMED MEDIZIN-TECHNIK GMBH.
Classification:   WIRE, SURGICAL
Generic Device Name:   VARIOUS TYPES OF WIRES, SURGICAL
Proprietary Device Name:   NORMED
Registered Establishment Name:  NORMED MEDIZIN-TECHNIK GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NORMED MEDIZIN-TECHNIK GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NORMED MEDIZIN-TECHNIK GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NORMED MEDIZIN-TECHNIK GMBH.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   ORTHOPEDIC MNUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NORMED MEDIZIN-TECHNIK GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS, SURGICAL, CARDIO-VASCULAR SCISSORS, ENR-SCISSORS, MICRO-SURGICAL
Proprietary Device Name:   SCISSORS, SURGICAL, CARDIO-VASCULAR SCISSORS, ENR-SCISSORS, MICRO-SURGICAL
Registered Establishment Name:  HANS SATTLER.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC RONGEURS
Proprietary Device Name:   ORTHOPEDIC RONGEURS, INCL. STELBRINK & LEMPERT RONGEURS
Registered Establishment Name:  MEDE TECHNIK.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WIRE TWISTING FORCEPS
Proprietary Device Name:   WIRE TWISTING FORCEPS
Registered Establishment Name:  MEDE TECHNIK.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WIRE AND PIN CUTTERS
Proprietary Device Name:   WIRE CUTTER, PIN CUTTER (VARIOUS TYPES)
Registered Establishment Name:  MEDE TECHNIK.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC FORCEPS
Proprietary Device Name:   PLATYPUS NAIL PULLING FORCEPS AND OTHER TYPES OF ORTHOPEDIC FORCEPS
Registered Establishment Name:  MEDE TECHNIK.
Classification:   TAP, BONE
Generic Device Name:   TAP
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WEBER INSTRUMENTE GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WEBER INSTRUMENTE GMBH.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WEBER INSTRUMENTE GMBH.
Classification:   BENDER
Generic Device Name:   VARIOUS BENDERS FOR ORTHOPEDIC USE
Proprietary Device Name:   BENDERS FOR ORTHOPEDIC USE, VARIOUS MODELS
Registered Establishment Name:  WEBER INSTRUMENTE GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT, VARIOUS TYPES & MODELS
Registered Establishment Name:  WEBER INSTRUMENTE GMBH.
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   HIP IMPLANT SYSTEM
Proprietary Device Name:   CUSTOM MADE HIP IMPLANT SYSTEM
Registered Establishment Name:  FEHLING INSTRUMENTS GMBH.
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   HIP IMPLANT SYSTEM
Proprietary Device Name:   IMPLANT, FIXATION DEVICE, SPINAL
Registered Establishment Name:  FEHLING INSTRUMENTS GMBH.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  FEHLING INSTRUMENTS GMBH.
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   DRILL BIT
Registered Establishment Name:  FEHLING INSTRUMENTS GMBH.
Classification:   TAP, BONE
Generic Device Name:   BONE TAP
Proprietary Device Name:   BONE TAP
Registered Establishment Name:  FEHLING INSTRUMENTS GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GS-VERPACKUNGSFOLIE.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS FORMS OF ARTHROSCOPY KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KALTEC PTY. LTD..
Classification:   POSITIONER, SOCKET
Generic Device Name:   PACTAN POSITIONING DEVICE
Proprietary Device Name:   PACTAN
Registered Establishment Name:  KALTEC PTY. LTD..

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Last Modified: 29 April 2006
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